The Register states that the FDA “is proposing to reclassify surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class II to class III. FDA is proposing this reclassification based on the tentative determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this device.”

For clarity, the FDA medical device classification system is based on safety and likelihood to perform intended device function. There are three classes in all: Class I contains items such as dental floss, Class II contains items such as condoms, and Class III contains items such as replacement heart valves. The proposal by the FDA to move vaginal mesh to a higher class indicates that the Agency finds vaginal mesh more dangerous than previously thought.

Because this research was published in widely-read journals, and vaginal mesh manufacturers failed to update warning labels or discontinue the product, a number of vaginal mesh lawsuits have been filed. Furthermore, writes Matthew Perrone of The Washington Post, “In February, U.S. District Judge Cheryl Eifert in southern West Virginia, who is handling most of the implant lawsuits, concluded that [Johnson and Johnson] destroyed thousands of documents regarding development of its pelvic-mesh implants, but said there was no proof that it was done intentionally. The documents would have included reports on patient testing of the mesh implants and could have shown whether participants suffered serious complications.”

As it currently stands, there are more than 20,000 vaginal mesh lawsuits pending against Johnson and Johnson alone, one of many vaginal mesh manufacturers.

If you or a loved one used transvaginal mesh and suffered complications or required surgery, you too may be eligible to file a transvaginal mesh lawsuit and gain significant financial compensation. For a free, no-obligation case consultation, contact our team of transvaginal mesh lawyers at the information provided below. We have the compassion, experience, and resources required to win the justice you deserve. Call today and see how we can help.

Johnson & Johnson (J&J) executives are currently under the microscope as to whether or not they engaged in criminal activity when they “lost” documents critical to lawsuits filed against them.

As we noted in previous posts, on February 4th, a federal magistrate judge ruled that Ethicon, a subsidiary of J&J, destroyed or lost documents that should have been preserved in anticipation of litigation involving its pelvic mesh devices. However, the judge also found that Ethicon’s loss of evidence was negligent, rather than willful or deliberate.

Nevertheless, advocates for women injured by J&J’s products recently urged the U.S. Department of Justice to investigate whether J&J actually did intentionally destroy the documents. Specifically, on March 26, 2014, a patient advocacy consumer group called, the Corporate Action Network, filed a complaint with the Department of Justice, asking Attorney General, Eric Holder, to investigate whether or not J&J executives engaged in criminal activity by destroying records in a federal probe. In its letter, the group stated:

“We respectfully request that you investigate Johnson and Johnson, Inc. and its top executives including Chairman and CEO, Alex Gorsky, for two possible criminal violations: first, for obstruction of a criminal investigation of health care offenses in apparent violation of 18 U.S.C. Section 1518 and second, for destruction of documents in apparent violation of 18 U.S.C. Section 1519. This request follows the recent discovery of document destruction by Johnson and Johnson as related to lawsuits brought against them by thousands of women across the United States who have been seriously injured by the corporation’s pelvic mesh implants.”

Essentially, advocates have pushed for a criminal investigation into whether J&J executives committed the crime of tampering with evidence, which includes knowingly destroying or altering documents “in contemplation of” an investigation or other proceeding by the federal government that may occur in the future. (18 U.S.C. § 1519.)

As we stated in one of our past articles entitled, Ethicon and its Faulty Pelvic Mesh Devices: Destroying Valentine’s Day…and Implicating Documents, we can only guess that the conveniently missing documents were ones that did not paint J&J in a good light. But whether J&J deliberately destroyed the documents, or lost them due to its own negligence, the outcome is the same: The documents are gone. And it’s to the plaintiffs’ detriment.

The Law Offices of Justinian Lane remain committed to helping women who have been severely injured by pelvic mesh devices. We continue to offer free consultations to prospective clients, so if you have been harmed by pelvic mesh, please contact our law firm for more information.

Two weeks ago was Valentine’s Day— a holiday that is supposed to be full of romance and heartfelt encounters with those you love. For many lucky people, Valentine’s Day was exactly that this year. Countless couples across the country could be seen on dates, filling restaurants, theaters, and dance-halls to capacity. Recent winter storms inspired hot tubbing rendezvous and even spontaneous trips to various resorts, hotels, and beaches, where an amorous evening awaited.

However, for many women this year, February 14th was a far cry from a joyous occasion. It was like all their other recent days—full of pain, discomfort, and bleeding. As a result, the holiday seemed only to mock them. These women were in too much pain to enjoy any kind of intimate evening, and too infected to even think about putting on a swimsuit for a night of hot tubbing. For these women, it seemed Valentine’s Day, which was originally named after a martyr, had reverted back to its traditional meaning—a day representing, not romance, but suffering and sacrifice.

The pain that these women are experiencing is due to surgical pelvic mesh devices that were designed, manufactured, marketed, and sold by a variety of companies, including Ethicon Inc. (hereinafter “Ethicon”), a subsidiary of Johnson & Johnson. The devices are pretty much what they sound like—pieces of mesh implanted pelvically in women. These devices are also referred to as pelvic slings, vaginal slings, and transobturator slings, and are intended to treat stress urinary incontinence and especially pelvic organ prolapse, which can occur in women after birth or surgery. Unfortunately, instead of helping women, some of the devices have only added to the women’s sufferings.

Women who have been injured by these surgical mesh devices have rightfully initiated legal proceedings against Ethicon and other manufacturers of pelvic mesh devices. The multidistrict litigation is still ongoing. The plaintiffs in these actions have mostly complained about two specific product lines: TVT and Prolift. The plaintiffs state that the devices erode internal vaginal tissue, causing bleeding and infection. As if that isn’t enough, plaintiffs are now faced with the cost of surgically removing the devices, or the worse alternative—leaving the devices in and inevitably facing even further injury.

The plaintiffs allege design defects, manufacturing defects, negligence, failure to warn, and breach of express and implied warranties. By now, so many women have been hurt by these faulty products, that literally thousands of additional cases have been joined in the pelvic mesh multidistrict litigation since its initiation.

If you have been injured by any brand of pelvic mesh, including Ethicon, you are welcome to call us for a free consultation. You may be entitled to financial compensation for your pain and suffering and for any medical expenses you incur due to the mesh.

Part II: Destroying Implicating Documents

A lot of us kept diaries or journals when we were teenagers. Now, if your family was anything like mine growing up, you know that keeping a journal is a risky business. After all, a teenager’s journal often proves tempting bait for snooping siblings and concerned parents.

Whenever I was concerned that prying eyes would read something I would prefer to keep private, I would either (1) rip out the particularly incriminating journal entries and destroy them somehow; or (2) hide them somewhere I thought no one would ever look, with the plan to tape them back into my journal later, after the coast was clear. Sometimes when I went with this second option, I hid the journal entries so well that when I genuinely tried to find the pages later, I couldn’t.

Ethicon, the company that sold faulty pelvic mesh devices, recently found itself in a similar, yet much more serious situation. Due to the vast amount of cases filed against Ethicon, Ethicon’s in-house counsel issued a “Hold Notice” directing employees to preserve all documents pertaining to the TVT and Prolift product lines, as well as other products involved in the ongoing litigation.

Plaintiffs claimed that after the duty to preserve evidence had been triggered, defendant Ethicon lost or destroyed tens of thousands of documents that likely contained information relevant to plaintiffs’ claims. If the missing records are anything like my journal entries, I’m guessing the conveniently missing documents were ones that did not paint Ethicon in a good light.

On February 4th, a federal magistrate judge ruled that Ethicon destroyed or lost documents that should have been preserved in anticipation of litigation involving its pelvic mesh devices. The judge also found that Ethicon’s loss of evidence was negligent, rather than willful or deliberate.

Like my journal entries, whether Ethicon deliberately destroyed the documents, or lost them due to its own negligence, the outcome is the same: The documents are gone. As a result, the judge found that plaintiffs are entitled to monetary sanctions to compensate them for the additional time spent by their counsel piecing together missing custodial files and preparing for depositions of key employees for whom scant information was provided by Ethicon. (In Re: Ethicon, Inc. Pelvic Repair Systems Product Liability Litigation, MDL Docket No. 2327, No. 2:12-md-2327, S.D. W.Va.; See 12/5/13, Page 9).

Further, the federal magistrate judge recommended allowing trial judges to instruct juries to find an adverse inference for missing evidence. Id. An “adverse inference” instruction tells the jury members that they are allowed to assume that the missing documents were in fact harmful to Ethicon’s case.

By destroying, losing, or “losing” documents, Ethicon has shown that it has just as little regard for the plaintiffs’ valuable time, as it does for their injuries. Our law firm, on the other hand, cares a great deal about the pain and inconvenience people have endured due to pelvic mesh. If you have had complications with a pelvic mesh device, we would be honored to work on your behalf, and hope that you will call us for a free consultation.

Over the course of the past several days, Ethicon, a Johnson & Johnson company, has crowed over the fact that it “prevailed” in a lawsuit regarding the pelvic mesh devices it manufactured and promoted. At first glance, the media headlines regarding Ethicon’s recent “triumph” are confusing, and might even make it seem like Ethicon has already won the overall multidistrict litigation. This is far from the truth, so we thought we would set the record straight.

All that has happened is that a federal court has thrown out one woman’s lawsuit. Specifically, on February 18, 2014, Judge Joseph R. Goodwin found that the plaintiff, Carolyn Lewis, failed to show proof of a defective product in her case. As a result, the court granted Ethicon’s motion for directed verdict. See In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL Docket No. 2327, Carolyn Lewis, et al. v. Johnson & Johnson, et al., No. 2:12-4301, S.D. W.Va.

The lawsuit filed by Carolyn Lewis was the first bellwether trial against Ethicon before Judge Goodwin. “Bellwether” trials are early cases designed to help the parties test how the court and juries may respond to evidence and testimony that is likely to be similar to what is offered in other cases. However, each individual plaintiff has to establish her own case and show that the product caused her injury. The outcome of any bellwether trials are not binding on other cases in the litigation. (For more on bellwether cases, check out: Vaginal Mesh Cases and Neutered Sheep – What’s the Connection?)

In no way do we minimize the disappointment many feel as a result of the ruling in Ms. Lewis’ case. However, not all is lost for other plaintiffs or potential plaintiffs. The facts of each and every case are different and may therefore have very different outcomes. Prior to this year, at least three other pelvic mesh cases went to trial, including two cases that went before state court juries and one case in federal court. In all three cases, plaintiffs triumphed and received multi-million dollar damage awards from the jury.

With all this said, Ethicon needs to hold off on doing any kind of victory dance. In the grand scheme of things, one motion for a directed verdict in Ethicon’s favor is far from an overall triumph. Ethicon faces months and months of future litigation, as do other manufacturers and promoters of pelvic mesh devices. According to a case list released by the U.S. Judicial Panel on Multidistrict Litigation, Judge Goodwin is currently presiding over 12,992 Ethicon mesh lawsuits, 13,292 AMS mesh lawsuits, 7,617 Boston Scientific mesh lawsuits, 6,172 Bard Avaulta mesh lawsuits, 1,155 Coloplast mesh lawsuits and 152 Cook Medical mesh lawsuits.

We would welcome the opportunity to help any woman injured by Ethicon pelvic mesh.

Right now, thousands of vaginal mesh lawsuits are pending in the U.S. District Court for the Southern District of West Virginia. Just as the criminal justice system would collapse if every criminal case went to trial, so too would our civil justice system collapse if every vaginal mesh case went to trial. The vaginal mesh cases are all grouped together in what is called an MDL, which stands for “Multi-District Litigation.” An MDL is used when there are a variety of similar lawsuits filed in different federal court districts across the country. (There are 94 federal districts.)

There are several purposes of an MDL, but one of the most practical is to facilitate settlement of the hundreds or thousands of cases that are part of the MDL. An MDL facilitates settlements through a series of special trials. In a nutshell, the court picks a handful of cases to be tried. The results of those trials then give both sides some idea of what juries are likely to do with any given case. The parties can then decide upon terms of a mass settlement based upon the results of those trials.

The cases that the judge pick for trial have a special name: “Bellwether cases.” You might guess that “Bellwether” is some fancy Latin term. It actually is a fancy farming term. In the vaginal mesh MDL, one of the mesh manufacturers filed a memorandum that explains the history of the term Bellwether:

[T]he etymology of the word “bellwether” refers to a neutered ram (a wether) with a large bell around its neck, responsible for keeping a flock of sheep together. In Judge Kramer’s words, the bellwether helps the flock “stay in line and follow him, so that there are no stragglers off doing their own thing, and they all go home together at the end of the day.” Judge Kramer drew the analogy to a bellwether case, adding that like the ram, it is very important that a bellwether case is not a “sexy” case – in other words, that it has no facts that would make it an outlier case or make it more favorable for one side or the other. He continued with the analogy, saying it was also important that the “other sheep don’t know that the wether isn’t sexy anymore” so that they continue to follow him and stay “with the flock” and so they can all “go home at the same time.”

The vaginal mesh manufacturer filed the memorandum because it does not want some of the proposed cases to be used as bellwethers. The manufacturer argues that several of the cases are too “sexy.” Sexy in this case of course means that the cases might lead to large jury verdicts against the manufacturer.

While the memorandum does a good job in arguing that all bellwether cases should be “run of the mill” and not extraordinary, that’s not really what the manufacturer would prefer. Both sides want bellwether cases to be better than average, so the resulting jury verdicts can be used to negotiate a favorable settlement. Politely worded motions aside, we do have an adversarial civil justice system.

I’ve attached the entire vaginal mesh lawsuit memorandum if you’d like to read it. Since it contains a great deal of personal information, I’ve gone ahead and redacted the names of the proposed bellwether picks.

Pelvic organ prolapse is a common condition among aging women, characterized by the shifting of pelvic organs, which push up against the vaginal walls. The condition may occur as a result of surgery or childbirth and oftentimes causes pain or discomfort. One method of treating prolapse is to use a synthetic polypropylene mesh to provide mechanical support for the failing inner vaginal walls, and various different kinds of meshes have been created for this procedure. The article discussed below states, “High stiffness meshes, i.e. those resistant to stretch when deformed, have been purported to directly influence the rate of mesh-related complications.”

The authors of the study concluded that “The most significant findings of this study were that the stiffer and heavier mesh Gynemesh PS had a profoundly negative impact on vaginal morphology and the structural proteins that maintain the integrity of the vagina relative to sham-operated controls.” Sham-operated controls, in this study, refers to subjects that underwent the same surgical procedure without implantation of the mesh. The authors go on to state that stiffer, heavier, and less porous meshes were more commonly associated with negative outcomes for the subjects. In this study specifically, Gynemesh PS was associated with the highest rate of complications, whereas UltraPro and SmartMesh did not show the same degeneration of vaginal tissues.

Sadly, many women use transvaginal mesh kits without knowing the rate of failure associated with TVM, and/or without being informed of the possible harmful side-effects TVM use carries. Because of this lack of oversight by TVM manufacturers, vaginal mesh lawsuits have been filed in great number around the world.

One such study, titled “Two-Year Outcomes After Vaginal Prolapse Reconstruction With Mesh Pelvic Floor Repair System,” was conducted by Marianna Alperin, et at. The study was published in the journal of Female Pelvic Medicine & Reconstructive Surgery. “The aim of this prospective observational study was to investigate anatomical and functional outcomes 2 years after prolapse repair using the Prolift mesh kits.” Functional outcomes were evaluated with questionnaires assessing pelvic symptoms, quality of life, sexual function, and global satisfaction. Anatomical data were collected by conducting a pelvic examination for anatomical support and mesh complications; the Pelvic Organ Quantification (POPQ) examination was used to measure uterine and vaginal support.

Study participants included 85 women, who had enrolled in a similar previous one-year study. At the two-year follow-up subjective, or functional, outcomes were evaluated for 82 women. While objective, or anatomical, data was collected for 79 of the participants. Of all the procedures evaluated 55% were total prolift procedures, 29% anterior prolift, and 15% posterior prolift. Prolapse was very common among the participants, although none suffered beyond stage III. Sixty-five percent of the participants experienced only stage 0/I prolapse, 31% were treated for stage II prolapse, while only 4% of the participants were treated for stage III prolapse.

This particular study concluded that procedures using TVM are for the most part quite effective. The author states “These data show that at the 2-year follow-up, the Profit system achieves anatomical support, significant symptom relief, and high patient satisfaction. However, mesh exposure and new-onset prolapse of the non-operated compartment are not uncommon.”

If you or a loved one used transvaginal mesh and experienced a harmful side effect of vaginal mesh, you may be entitled to significant financial compensation. For more information or a free, no-obligation case consultation, contact our team of transvaginal mesh lawyers at the information provided below.

Several studies have been conducted, evaluating the effectiveness of transvaginal mesh (TVM) usage in treating damaged vaginal tissues. Initial studies primarily focused on the anatomical success of TVM, with less emphasis on functional outcome. Dr. Salil Khandwala conducted a study titled “Transvaginal Mesh Surgery for Pelvic Organ Prolapse: One-Year Outcome Analysis,” published in the journal of Female Pelvic Medicine & Reconstructive Surgery (www.fpmrs.net). “The primary objective of this study was to assess success based on both subjective and objective criteria at 1 year after the PP-PG vaginal mesh surgery for genital organ prolapse. The secondary objectives were to assess complications and also the impact of surgery on urinary incontinence, vaginal healing, and sexual function.” In this study ‘objective criteria’ refers to anatomical success, as in whether or not the mesh is physically performing it’s intended use. While ‘subjective criteria’ focused more on the patient’s satisfaction, as in any pain or discomfort after intervention.

This study analyzed data from 157 total participants treated with TVM for pelvic organ prolapse (POP) including 5 anterior, 48 posterior, and 104 total mesh procedures. After the initial procedure, 44 subjects experienced only stage II prolapse, while 91 subjects had stage III prolapse, and 22 were treated for stage IV prolapse.

The data appeared to show that TVM may in fact be reliable in treating POP, and similar conditions. The author states, “This prospective cohort study provides evidence that the PP-PG transvaginal mesh procedure results in improvement in both function and anatomy at 1 year in subjects with pelvic organ prolapse.” It was reported that patients experienced improvement of vaginal bulge perception, with no cases of mesh retraction in this study. While patients experienced different stages of prolapse, ultimately none showed greater than stage IV recurrence, which contradicts previous studies suggesting that stage III or IV prolapses occur in up to 75% of TVM procedures.

This study suggests that PP-PG transvaginal mesh surgery is both safe and effective, however the study is limited. For example, this study did not examine long term effects, as it was limited to only a 12 month follow up.

If you or a loved one used transvaginal mesh and would like more information about TVM or vaginal mesh lawsuits, please do not hesitate to contact our team of vaginal mesh lawyers at the information provided below.

Stress urinary incontinence is a condition characterized by the inability to hold urine while under physical stress, even as mild as coughing or sneezing. One method of treating such cases, which has rapidly grown more popular recently, involves the use of a sling. The sling is used in order to avoid complications associated with the process of grafting autologous tissues (tissues from another part of the patient’s body). On the other hand, purely synthetic materials are known to be durable, but put the patient at risk of suffering vaginal and urethral erosion. Therefore, hybrid systems have been created to avoid such problems. “The BioArc sling system (American Medical Systems, Minnetonka, Minn) is a hybrid sling system that uses polypropylene mesh for fixation and a biological graft for suburethral support.”

Gary Bong and Eric Rovner published a study titled “Vaginal Erosion After Hybrid Midurethral Sling Placement” through the Department of Urology in the Medical University of South Carolina. The report is a case study, covering the first case of vaginal erosion after implantation of the midurethral hybrid sling.

The patient was a healthy 31 year old woman without any unusual prior medical or surgical history. She had undergone a previous procedure and suffered from dyspareunia (painful sexual intercourse due to medical or physiological causes) and persistent sensation of a vaginal “bulge” 5 months after sling placement. The doctors observed tenderness along the vaginal wall and visible erosion of the mesh sling. After re-intervention, in which the previous sling was removed and replaced with a new one, the patient’s symptoms no longer persisted. She was continent and had resumed normal intercourse with her husband.

Given that this was the first reported case study of its nature, the authors could not come to any definite conclusions. They did note, however, that “The hybrid BioArc system has been marketed as a technique for the treatment of female stress urinary incontinence that combines the ease of placement and durability of polypropylene mesh with the biologically compatible nature of autologous fascia and its low erosion rates.” However, the combined use of autologous materials with polypropylene mesh did not prevent erosion “it is likely that it was the polypropylene component that was responsible for the erosion seen in this case”. The authors concluded, in part, by asserting that future clinical trials are necessary to further evaluate the safety and efficacy of this system.

Since the risks associated with TVM use have gone undisclosed to patients and doctors alike, a number of lawsuits have been filed against the manufacturers of some TVM products. If you or a loved one used TVM and believe you may have a case, please do not hesitate to contact our team of TVM lawyers. We have the experience, resources, and skills required to win the justice you deserve, even from the largest of pharmaceutical companies.

Transvaginal mesh (TVM) is a mesh implant used to treat damaged vaginal tissues. One condition TVM has been commonly used to treat is called pelvic organ prolapse (POP). POP is characterized by weakening of the tissues that hold the pelvic organs in place, and occurs in 30-50% of women.

An observational study, titled “Total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse: a 5-year prospective follow-up study”, conducted by Bernard Jacquetin, et al. and published by The International Urogynecological Association in 2010, evaluated the long term effectiveness of procedures using TVM. More specifically, the purpose of the study was “to assess effectiveness, both anatomical and subjective, and complications for the TVM technique for POP repair.” The evaluations were conducted up to three years after implantation of TVM, with additional future evaluations scheduled at 5 years post-implantation. Subjects included women over the age of 21 treated for either anterior or posterior damage, and having already undergone a hysterectomy to limit confounding factors. Women suffering from uncontrolled diabetes or coagulation disorders were not included in the data set.

Effectiveness of TVM was evaluated based on “prolapse recurrence, defined as a POP-Q Stage II or more…or surgical intervention for recurrence of prolapse.” The data revealed an anatomical success rate of 81.2% three years post-operation; which is not significantly different from the success rate of 81.6% at one year post-implantation.

Some confounding variables in the study include the fact that different cuts of TVM, and different needles, were used depending on the nature of the procedure; therefore, the study technically did not evaluate a “standard” procedure. Ultimately the study concluded that transvaginal mesh, may in fact be a reliable solution for surgical repair of damaged vaginal tissues, stating that “the early positive anatomical findings and positive impact on patients’ quality of life scores are sustained after 3 years. The TVM procedure is associated with a high total reintervention rate (13.3%) but the low re-intervention rate for prolapse (3.3%) suggests that a total vaginal mesh seems to lead to a stable repair of the pelvic floor.”

Unfortunately, and in light of the publication of many similar studies showing the danger of transvaginal mesh, the many TVM product manufacturers have failed to warn women of the risks associated with their products. Because of this, a number of vaginal mesh lawsuits have been filed.

About this Blog

This blog chronicles legal and scientific news relating to personal injuries caused by defective drugs and medical devices. It is published by injury lawyer Justinian C. Lane, an attorney who takes a personal interest in each of his clients’ cases.